Atlas FDA

PDS* ABSORBABLE LIGATING CLIPS

FDA 510(k) clearance K812323 · decided 1981-11-16

Clearance details

K-number
K812323
Device name
PDS* ABSORBABLE LIGATING CLIPS
Applicant
ETHICON, Inc.
Decision
Substantially Equivalent
Date received
1981-08-17
Decision date
1981-11-16
Days to decision
91 days
Clearance type
Traditional
Product code
FZP
Device class
2
Regulation number
878.4300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips (K254231)Taiwan Surgical Corporation2026-07-20
InnoClip Disposable Clip Applier (K253903)Taiwan Surgical Corporation2025-12-22
InnoClip Clip Applier (K253781)Taiwan Surgical Corporation2025-12-22
Disposable Polymer Ligation Clips (K250643)Hangzhou Kangji Medical Instrument Co., Ltd.2025-11-20
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (K251054)Teleflex Medical2025-07-03
GEM ZIPCLIP (K242541)Synovis Micro Companies Alliance A Subsidiary of Baxter Int2025-01-15
SOLID CLIP™ Single Use Clip Applier (K221495)Medscope Biotech Co., Ltd.2024-07-18
Hem-o-lok® Ligating Clips (K232970)Teleflex Medical2024-01-12
angiOCCLUDE Ligating Clips (K230966)A2 Medical Systems, LLC2023-09-19
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313)Ethicon Endo Surgery, LLC2023-08-29
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480)Teleflex Medical2023-04-28
DuraFuse Clip and Applier System (K213813)Neuramedica, Inc.2022-07-22

Recalls involving this device

RecordFirmDate
ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. Ten cartridges are p recall (Z-0654-05)Ethicon Endo-Surgery2005-03-25
ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200. Ten cartridges are recall (Z-0655-05)Ethicon Endo-Surgery2005-03-25
ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridge recall (Z-0656-05)Ethicon Endo-Surgery2005-03-25
ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are p recall (Z-0657-05)Ethicon Endo-Surgery2005-03-25

PMA approvals by this applicant

RecordFirmDate
ETHIZIA (P240035)ETHICON, Inc.2025-12-15
INTERCEED™ Absorbable Adhesion Barrier (P880047/S068)ETHICON, Inc.2025-12-12
SURGICEL® Absorbable Hemostats (N12159/S127)ETHICON, Inc.2025-12-12
SURGICEL® Absorbable Hemostats (N12159/S122)ETHICON, Inc.2025-11-04
SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126)ETHICON, Inc.2025-10-09
GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067)ETHICON, Inc.2025-10-09
SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125)ETHICON, Inc.2025-09-24
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S066)ETHICON, Inc.2025-09-24